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临床试验/NCT07545993
NCT07545993尚未招募不适用

Construction of a Multidimensional Dynamic Early Warning System for Genetic-Immune-Inflammatory Disorders in Precision Prevention and Control of Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study

Guangzhou Women and Children's Medical Center0 个研究点目标入组 1,050 人开始时间: 2026年4月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,050
主要终点
Bell stage II or higher NEC

研究概览

简要总结

Necrotizing enterocolitis (NEC) is one of the most severe gastrointestinal emergencies in preterm infants, characterized by insidious onset, rapid progression, and high mortality. It can lead to serious adverse outcomes such as intestinal perforation, short bowel syndrome, and neurodevelopmental disorders, making it a critical condition that significantly impacts the survival quality and long-term prognosis of preterm infants.With the advancement of perinatal medicine in China, the survival rates of extremely low and very low birth weight infants have been continuously improving. NEC has become a critical bottleneck constraining the quality of care and long-term prognosis for preterm infants.

Previous studies have demonstrated that various perinatal and early postnatal factors, including gestational age, birth weight, infection, feeding methods, blood transfusion, mechanical ventilation, and antibiotic exposure, are associated with the occurrence of NEC. However, these clinical factors still fail to adequately explain the interindividual variations in NEC incidence risk and disease severity under similar clinical exposure conditions.Existing NEC prediction models primarily rely on static baseline variables for one-time risk assessment, lacking dynamic risk updates during hospitalization, and most are derived from single-center retrospective studies.

With the application of clinical exome sequencing (CES), the role of genetic factors in susceptibility to NEC has gradually attracted attention.The research team has previously conducted NEC risk gene screening based on CES, genetic burden analysis, and exploration of genetic-clinical factor interactions, suggesting that genetic information can provide important supplementation for NEC risk assessment.Meanwhile, dynamic changes in immune-inflammatory markers such as peripheral blood eosinophils, NLR, absolute neutrophil count, and platelet count may already exhibit abnormalities prior to the onset of NEC, providing repeatable, low-cost, and clinically available signals for early identification.Based on this, this study aims to establish a multidimensional dynamic early warning system for NEC integrating single-center preliminary genetic research foundations with multi-center retrospective/prospective validation resources. This initiative seeks to enhance the identification capability of high-risk individuals and provide evidence for subsequent precision prevention and control as well as stratified management.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
0 Days 至 3 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Preterm infants with gestational age <32 weeks
  • Admission to the neonatology department of the lead institution or participating institutions
  • Parental consent to participate in the study and approval for genetic testing using residual samples from routine blood draws.
  • Possession of complete perinatal and hospitalization records.

排除标准

  • Congenital malformations, well-defined clinical syndromes, or chromosomal abnormalities
  • Death within 7 days after birth or voluntary discharge
  • Patients with confirmed positive diagnosis of pathogenic genes and interpretable major clinical phenotypes
  • Only one case of identical multiple births was retained for analysis to avoid genetic background overlap

研究组 & 干预措施

VPI

very preterm infants born <32 weeks

干预措施: No Intervention: Observational Cohort (Other)

结局指标

主要结局

Bell stage II or higher NEC

时间窗: From April 2026 to April 2029

次要结局

未报告次要终点

研究者

发起方
Guangzhou Women and Children's Medical Center
申办方类型
Other
责任方
Sponsor

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